ALLERGY 24-HR
- Product NDC
- 64679-987
- Requested package NDC
- 64679-987-17
- 11-digit product format
- 646790987
- Labeler code
- 64679
- Product ID
- 64679-987_f0f5c363-88c5-7177-e053-2a95a90a1a78
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- FEXOFENADINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Wockhardt USA LLC.
- Application
- ANDA079112
- Marketing category
- ANDA
- Marketing start
- 2012-02-08
- Marketing end
- 0000-00-00
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 180 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 64679-987 | 64679-987-17 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079112-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2012-02-08 | ||
| A079112-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2012-02-08 | ||
| A079112-003 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2012-02-08 | ||
| A079112-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2012-02-08 | ||
| A079112-005 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2012-02-08 | ||
| A079112-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2012-02-08 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A079112-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079112-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079112-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079112-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079112-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079112-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079112-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079112-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079112-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079112-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079112-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079112-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079112-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079112-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079112-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079112-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079112-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079112-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079112-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079112-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079112-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079112-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079112-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079112-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079112-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079112-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079112-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079112-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079112-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079112-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079112-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079112-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079112-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079112-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079112-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079112-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079112-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079112-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079112-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079112-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-08 | 03ed91905a0d… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64679-987-07 | Fexofenadine | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | 1 | |
| 64679-987-08 | Fexofenadine | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64679-987-09 | EA - Each | 64679-987 | a99e9d5d-19a7-4aef-9f24-6195937041c5 | 1 | 2015-06-09 |
| 64679-987-10 | EA - Each | 64679-987 | 18963b59-d80d-44ac-8692-7f082dd65e43 | 1 | 2015-06-09 |
| 64679-987-11 | EA - Each | 64679-987 | ef2c085c-61ce-4dfc-9320-f02f47381b91 | 1 | 2015-06-09 |
| 64679-987-12 | EA - Each | 64679-987 | 99dbc750-13a9-42b0-85b7-a995830794f8 | 1 | 2015-06-09 |
| 64679-987-13 | EA - Each | 64679-987 | 021e3a5d-fc06-4e43-9a62-a9afe30feb03 | 1 | 2015-06-09 |
| 64679-987-16 | EA - Each | 64679-987 | 19834fc4-eb77-40ea-b275-f3bbba76485e | 1 | 2019-07-02 |
| 64679-987-17 | EA - Each | 64679-987 | 22a99016-8654-4ff0-9b21-a0a527bacb48 | 1 | 2016-03-04 |
| 64679-987-20 | EA - Each | 64679-987 | f05034d8-bd1e-435e-913b-edfbc159f336 | 1 | 2016-03-04 |
| 64679-987-24 | EA - Each | 64679-987 | 87da958d-cb9f-406e-988f-f65346a5b794 | 1 | 2016-03-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64679-987 | ALLERGY 24-HR (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [WOCKHARDT USA LLC.] | 8 | Legacy NDC | 20221230_f4b394a6-8b4d-41ac-8962-82e81d85dd90.zip |
| 64679-987 | FEXOFENADINE TABLET, FILM COATED [WOCKHARDT USA LLC.] | 1 | Legacy NDC, 2 package rows | 20120404_9a5da651-483e-4e51-b822-12465930fa5c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 9a5da651-483e-4e51-b822-12465930fa5c | 1 |
| 997488 | fexofenadine HCl 30 MG Oral Tablet | PSN | 9a5da651-483e-4e51-b822-12465930fa5c | 1 |
| 997501 | fexofenadine HCl 60 MG Oral Tablet | PSN | 9a5da651-483e-4e51-b822-12465930fa5c | 1 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 9a5da651-483e-4e51-b822-12465930fa5c | 1 |
| 997488 | fexofenadine hydrochloride 30 MG Oral Tablet | SCD | 9a5da651-483e-4e51-b822-12465930fa5c | 1 |
| 997501 | fexofenadine hydrochloride 60 MG Oral Tablet | SCD | 9a5da651-483e-4e51-b822-12465930fa5c | 1 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 9a5da651-483e-4e51-b822-12465930fa5c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64679-987-17 | 64679098717 | 1000 TABLET, FILM COATED in 1 BOTTLE (64679-987-17) | 2012-02-08 | 0000-00-00 | No | No | Current |